Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category.
Material and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of CVD and meeting the inclusion criteria. Group 1 (n=75) will receive pitavastatin at a starting dose of 1 mg/day. Group 2 (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day and/or rosuvastatin to 40 mg/day will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months.
Results. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function.
Conclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.

Start Date05 Mar 2026

Sponsor / Collaborator

Moscow State University Lomonosov

[+1]

ChiCTR2600116912

/ Not yet recruitingNot ApplicableIIT

Chemotherapy plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer: An Exploratory Phase I Trial

Start Date01 Oct 2025

Sponsor / Collaborator

Shanghai Pulmonary Hospital

NCT06982131

/ RecruitingPhase 1

A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.

Start Date04 Jun 2025

Sponsor / Collaborator

Roche Holding AG

100 Clinical Results associated with Pitavastatin Calcium

100 Translational Medicine associated with Pitavastatin Calcium

100 Patents (Medical) associated with Pitavastatin Calcium

149

Literatures (Medical) associated with Pitavastatin Calcium

01 Oct 2025·Journal of Neurological Surgery Part B-Skull Base

Anatomy of Inferior Temporal Arteries in Relation to Middle Cranial Fossa Structures: A Postmortem Computed Tomography Angiography Study

Article

Author: Peters, David ; Cossu, Giulia ; Grabherr, Silke ; Daniel, Roy Thomas ; Bruguier, Christine ; Peters, David Richard ; Dunet, Vincent ; Magnin, Virginie ; Starnoni, Daniele ; Benes, Vladimir ; Bubenikova, Adela ; George, Mercy ; Gonzalez-Lopez, Pablo ; Giammattei, Lorenzo ; Messerer, Mahmoud

Abstract:

The inferior temporal arteries (ITAs), branches of the posterior cerebral artery (PCA), are critical vascular structures encountered during subtemporal surgical approaches. Anatomical data based on multiphase postmortem computed tomography angiography (MPMCTA) are provided as a tool for preoperative surgical planning to lower the risk of ITA injury.Adult (≥18 years) cases that underwent MPMCTA during 2015 to 2023 and whose cause of death did not involve the cerebral circulation were included in the study. Standardized measurements on four predefined coronal slices in relation to the posterior clinoid process (PCP) were established with references to projections in axial and sagittal planes. The main aim was to assess the presence, width, and course of anterior ITA (AITA), middle ITA (MITA), and posterior (PITA) particularly within the individual established quadrants of the middle cranial fossa.A total of 74 hemispheres were studied among 37 patients with the mean age of 52 ± 20.2 years. PITA was present in 98.7% of studied hemispheres, followed by MITA in 90.7% and AITA in 89.2%. The course of PITA was straight (65.8%) or oblique (34.3%), with significant difference in mean width (p = 0.050), branching angle (p < 0.001), distance to tentorial hiatus (p < 0.001), and superior petrosal sinus (p < 0.001). A pattern of PITA loop was defined as a twisting of its course within the collateral sulcus. Significant relationship between the presence of AITA and MITA (p < 0.001) along with the co-presence of AITA and PITA (p = 0.029) was found.Knowledge of ITA characteristics and their relationship to surrounding anatomical structures is vital in subtemporal neurosurgical interventions. Preoperative inspection of the collateral sulcus and its relation to the surgical trajectory is critical to prevent PITA injury.

01 Sep 2025·EUROPEAN ARCHIVES OF PSYCHIATRY AND CLINICAL NEUROSCIENCE

A comparison between rTMS and antidepressant medication on depressive symptom clusters in treatment-resistant depression

Article

Author: de Waardt, Dieuwertje ; Wijnen, Ben ; van Mierlo, Hans ; Arns, Martijn ; Dalhuisen, Iris ; van Exel, Eric ; Biemans, Tom ; Vos, Cornelis F ; Spijker, Jan ; van Oostrom, Iris ; Janzing, Joost ; Hark, Sophie Ter ; Tendolkar, Indira ; van Eijndhoven, Philip

Abstract:

Background:

Antidepressive treatment outcomes can be assessed using sum scores from measurement scales, but symptom clusters may better capture the multidimensional structure of depression. Little is known about the comparative effectiveness of different treatment modalities on these clusters. We sought to evaluate the effects of rTMS and antidepressant medication on four symptom clusters and the extent to which these differ between treatments. In addition, we assessed whether baseline cluster scores predicted (non)response.

Methods:

Data were obtained from two clinical trials (DETECT: rTMS vs. medication; PITA: tricyclic antidepressants). Primary outcomes were symptom cluster scores: ‘General Depression’, ‘Anxiety’, ‘Somatic Symptoms’ and ‘Insomnia’. In the primary analysis based on DETECT, a MANCOVA comparing rTMS with medication was performed. For validation, a MANCOVA was performed replacing medication data from DETECT with data from PITA. Baseline symptom cluster scores were compared between responders and non-responders, as well as treatment groups.

Results:

In both the primary and validation analyses, no difference was seen between rTMS and medication on the symptom clusters. Similar patterns of response were observed in all groups, with ‘Insomnia’ showing the greatest effect of treatment. Baseline cluster scores did not predict treatment response.

Conclusions:

We did not find a differential effect of rTMS or antidepressant medication on depressive symptom clusters. Both treatments demonstrated comparable response patterns for all clusters, and baseline cluster scores did not differ between responders and non-responders. Future studies with larger samples or more homogeneous treatments may elucidate the role of symptom clusters as a tool for more individualized treatment.

Trial registration:

PITA NCT03548675 DETECT The Netherlands Trial Register NL7628.

01 Mar 2025·JAMA Cardiology

Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HIV

Article

Author: Grinspoon, Steven K. ; Fichtenbaum, Carl J. ; deFilippi, Christopher ; Diggs, Marissa R. ; Foldyna, Borek ; Douglas, Pamela S. ; Lu, Michael T. ; Sadreyev, Ruslan ; McCallum, Sara ; Curran, Adrian ; Eckard, Allison Ross ; Currier, Judith ; Fitch, Kathleen V. ; Malvestutto, Carlos D. ; Karady, Julia ; Bloomfield, Gerald S. ; Aberg, Judith A. ; Mayrhofer, Thomas ; Taron, Jana ; Kolossváry, Márton ; Ribaudo, Heather J. ; Zanni, Markella V. ; Centinbas, Murat ; Schnittman, Samuel R.

Importance:

In a mechanistic substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) randomized clinical trial, pitavastatin reduced noncalcified plaque (NCP) volume, but specific protein and gene pathways contributing to changes in coronary plaque remain unknown.

Objective:

To use targeted discovery proteomics and transcriptomics approaches to interrogate biological pathways beyond low-density lipoprotein cholesterol (LDL-C), relating statin outcomes to reduce NCP volume and promote plaque stabilization among people with HIV (PWH).

Design, Setting, and Participants:

This was a post hoc analysis of the double-blind, placebo-controlled, REPRIEVE randomized clinical trial. Participants underwent coronary computed tomography angiography (CTA), plasma protein analysis, and transcriptomic analysis at baseline and 2-year follow-up. The trial enrolled PWH from April 2015 to February 2018 at 31 US research sites. PWH without known cardiovascular diseases taking antiretroviral therapy and with low to moderate 10-year cardiovascular risk were eligible. Data analyses were conducted from October 2023 to February 2024.

Intervention:

Oral pitavastatin calcium, 4 mg per day.

Main Outcomes and Measures:

Relative change in plasma proteomics, transcriptomics, and noncalcified plaque volume among those receiving treatment vs placebo.

Results:

Among 558 individuals (mean [SD] age, 51 [6] years; 455 male [82%]) included in the proteomics assessment, 272 (48.7%) received pitavastatin and 286 (51.3%) received placebo. After adjusting for false discovery rates, pitavastatin increased abundance of procollagen C-endopeptidase enhancer 1 (PCOLCE), neuropilin 1 (NRP-1), major histocompatibility complex class I polypeptide-related sequence A (MIC-A) and B (MIC-B), and decreased abundance of tissue factor pathway inhibitor (TFPI), tumor necrosis factor ligand superfamily member 10 (TRAIL), angiopoietin-related protein 3 (ANGPTL3), and mannose-binding protein C (MBL2). Among these proteins, the association of pitavastatin with PCOLCE (a rate-limiting enzyme of collagen deposition) was greatest, with an effect size of 24.3% (95% CI, 18.0%-30.8%; P &lt; .001). In a transcriptomic analysis, individual collagen genes and collagen gene sets showed increased expression. Among the 195 individuals with plaque at baseline (88 [45.1%] taking pitavastatin, 107 [54.9%] taking placebo), changes in NCP volume were most strongly associated with changes in PCOLCE (%change NCP volume/log2-fold change = −31.9%; 95% CI, −42.9% to −18.7%; P &lt; .001), independent of changes in LDL-C level. Increases in PCOLCE related most strongly to change in the fibro-fatty (&lt;130 Hounsfield units) component of NCP (%change fibro-fatty volume/log2-fold change = −38.5%; 95% CI, −58.1% to −9.7%; P = .01) with a directionally opposite, although nonsignificant, increase in calcified plaque (%change calcified volume/log2-fold change = 34.4%; 95% CI, −7.9% to 96.2%; P = .12).

Conclusions and Relevance:

Results of this secondary analysis of the REPRIEVE randomized clinical trial suggest that PCOLCE may be associated with the atherosclerotic plaque stabilization effects of statins by promoting collagen deposition in the extracellular matrix transforming vulnerable plaque phenotypes to more stable coronary lesions.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02344290

News (Medical) associated with Pitavastatin Calcium

02 Mar 2026

·www.biospace.com

Palvella Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

WAYNE, Pa., March 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (“Palvella”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it closed its previously announced upsized public offering on February 27, 2026. The offering consisted of 1,840,000 shares of its common stock, which included the exercise in full of the underwriters’ option to purchase 240,000 additional shares, at a price to the public of $125.00 per share. The aggregate gross proceeds to Palvella from this offering, before deducting underwriting discounts and commissions and offering expenses, were $230.0 million. TD Cowen, Cantor, Stifel, Mizuho, LifeSci Capital, Oppenheimer & Co., Canaccord Genuity and H.C. Wainwright & Co. acted as joint bookrunning managers for the offering. Lucid Capital Markets, Jones, Clear Street and Craig-Hallum acted as co-managers for the offering. Palvella intends to use the net proceeds from this offering to support the development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes, including research and development expenses. The shares were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-292544) that was declared effective by the Securities and Exchange Commission (“SEC”) on January 29, 2026. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website at Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com ; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59 th Street, 6 th Floor, New York, NY 10022 or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364‐2720 or by email at syndprospectus@stifel.com . This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. About Palvella Therapeutics Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the topical treatment of disseminated superficial actinic porokeratosis. QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication. Caution Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of Palvella’s management. Such forward-looking statements include, without limitation, statements relating to the use of proceeds from the public offering of common stock. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others, the risks and uncertainties set forth in the “Risk Factors” section and elsewhere in the prospectus supplement related to the public offering filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission and available at including but not limited to Palvella’s periodic reports, including Palvella’s most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Palvella assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Contact Information: Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media: Marcy Nanus Managing Partner, Trilon Advisors LLC mmanus@trilonadvisors.com

26 Feb 2026

·www.biospace.com

Palvella Therapeutics Announces Pricing of Upsized Public Offering

WAYNE, Pa., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (“Palvella”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the pricing of its upsized public offering of 1,600,000 shares of its common stock at a price to the public of $125.00 per share. In addition, Palvella has granted the underwriters a 30-day option to purchase up to an additional 240,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Palvella from this offering are expected to be $200 million, before deducting underwriting discounts and commissions and other offering expenses, assuming no exercise of the underwriters’ option to purchase additional shares. All shares of common stock are being offered by Palvella. The offering is expected to close on or about February 27, 2026, subject to the satisfaction of customary closing conditions. TD Cowen, Cantor, Stifel, Mizuho, LifeSci Capital, Oppenheimer & Co., Canaccord Genuity and H.C. Wainwright & Co. are acting as joint bookrunning managers for the offering. Lucid Capital Markets, Jones, Clear Street and Craig-Hallum are acting as co-managers for the offering. Palvella intends to use the net proceeds from this offering to support the development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes, including research and development expenses. The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-292544) that was declared effective by the Securities and Exchange Commission (“SEC”) on January 29, 2026. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available for free on the SEC’s website at A final prospectus supplement with the final terms of the offering and accompanying prospectus will be filed with the SEC and will be available for free on the SEC’s website at Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com ; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59 th Street, 6 th Floor, New York, NY 10022 or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364‐2720 or by email at syndprospectus@stifel.com . This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. About Palvella Therapeutics Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the topical treatment of disseminated superficial actinic porokeratosis. QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication. Caution Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of Palvella’s management. Such forward-looking statements include, without limitation, statements relating to the completion, use of proceeds and anticipated total gross proceeds from the offering. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the public offering, and other risks and uncertainties related to the public offering, as well as the risks and uncertainties set forth in the “Risk Factors” section and elsewhere in the prospectus supplement related to the public offering filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission and available at including but not limited to Palvella’s periodic reports, including Palvella’s most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Palvella assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Contact Information: Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media: Marcy Nanus Managing Partner, Trilon Advisors LLC mnanus@trilonadvisors.com

25 Feb 2026

·www.biospace.com

Palvella Therapeutics Announces Proposed Public Offering

WAYNE, Pa., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (“Palvella”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it has commenced an underwritten public offering of $150.0 million of shares of its common stock. In addition, Palvella expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. All shares of common stock to be sold in the proposed offering are to be sold by Palvella. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the proposed offering. TD Cowen, Cantor, Stifel, Mizuho, LifeSci Capital, Oppenheimer & Co., Canaccord Genuity and H.C. Wainwright & Co. are acting as joint bookrunning managers for the offering. Lucid Capital Markets, Jones, Clear Street and Craig-Hallum are acting as co-managers for the offering. Palvella intends to use the net proceeds from the proposed offering to support the development of its programs, including QTORIN rapamycin and QTORIN pitavastatin, and for working capital and other general corporate purposes, including research and development expenses. The proposed offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-292544) that was declared effective by the Securities and Exchange Commission (“SEC”) on January 29, 2026. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website at Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained, when available, from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com ; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59 th Street, 6 th Floor, New York, NY 10022 or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364‐2720 or by email at syndprospectus@stifel.com . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. About Palvella Therapeutics Founded and led by rare disease drug development veterans, Palvella is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the topical treatment of disseminated superficial actinic porokeratosis. QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication. Caution Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of Palvella’s management. Such forward-looking statements include, without limitation, market conditions, statements relating to the completion, timing, size, use of proceeds of the proposed public offering on the anticipated terms or at all and the grant of the option to the underwriters to purchase additional shares of common stock. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering, completion of the proposed public offering on the anticipated terms or at all, and other risks and uncertainties related to the proposed public offering, as well as the risks and uncertainties set forth in the “Risk Factors” section and elsewhere in the preliminary prospectus supplement related to the proposed public offering filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission and available at including but not limited to Palvella’s periodic reports, including Palvella’s most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Palvella assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Contact Information: Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media: Marcy Nanus Managing Partner, Trilon Advisors LLC mnanus@trilonadvisors.com

100 Deals associated with Pitavastatin Calcium

External Link

KEGG	Wiki	ATC	Drug Bank
D01862	Pitavastatin Calcium	C10AA08	DB08860

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Complex dyslipidemia	Brazil	Libbs Farmacêutica Ltda.	24 Jun 2019
Primary Hyperlipidemia	Brazil	Libbs Farmacêutica Ltda.	24 Jun 2019
Hyperlipidemia, Familial Combined	United States	Kowa Co., Ltd.	16 May 2019
Heterozygous familial hypercholesterolemia	Australia	Advantage Medical Products LLC	27 Aug 2013
Dyslipidemias	China	Kowa Co., Ltd.	28 Sep 2008
Hyperlipidemias	China	Kowa Co., Ltd.	28 Sep 2008
Hypercholesterolemia	Japan	Kowa Co., Ltd.	17 Jul 2003
Hypercholesterolemia, Familial	Japan	Kowa Co., Ltd.	17 Jul 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	United States	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Botswana	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Brazil	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Canada	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Haiti	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	India	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Peru	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	South Africa	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Spain	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Thailand	Kowa Pharmaceuticals America, Inc.	26 Mar 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02344290 (REPRIEVE, Pubmed \| JACC Cardiovasc Imaging)	Phase 3	HIV Infections	753	Pitavastatin	osonuxkkic(dcmjstjqsa) = yiocqovdce bbosmzvzim (oouohtqvqg )	Positive	01 Dec 2025
				Placebo	osonuxkkic(dcmjstjqsa) = ieawjlnamh bbosmzvzim (oouohtqvqg )
NCT02344290 (REPRIEVE, Pubmed \| AIDS)	Phase 3	HIV Infections	733	Pitavastatin	modwvxmnvt(uxfdwhgwaz) = piavakkixl vyirqsybfn (gtxlwyfvgz, 44.1 - 57.6) View more	Positive	10 Nov 2025
				Placebo	modwvxmnvt(uxfdwhgwaz) = yinejvtotd vyirqsybfn (gtxlwyfvgz, 44.0 - 57.9) View more
NCT02344290 (REPRIEVE, CTgov)	Phase 3	HIV Infections	7,769	Pitavastatin (Pitavastatin)	qojimchqns = vwcgydzfsm cfyaedvofx (sfbrtuxkxn, zriewncjqd - dipvtukpib) View more	-	15 Oct 2024
				Placebo (Placebo)	qojimchqns = ajethrtmcu cfyaedvofx (sfbrtuxkxn, opgpzsaiaq - mhaunuizcd) View more
NCT01710007 (CTgov)	Phase 3	Primary hypercholesterolemia \| Hypercholesterolemia	202	Lipitor (Lipitor)	jutchvtrtm(nbkddtoxth) = giprrwlbaq kudlwhigci (vjqzrvtojy, 12.80) View more	-	17 Jul 2023
				1PC002 (1PC002)	jutchvtrtm(nbkddtoxth) = dfmrjwfbnv kudlwhigci (vjqzrvtojy, 17.97) View more
NCT01695954 (CTgov)	Phase 1	Hyperlipidemias \| HIV Infections	34	Pitavastatin+Efavirenz (Arm A: (Pitavastatin and Efavirenz))	ujudbqlqov(ympscedbcn) = uulicqxnbr kmplaqgywa (qmirbetigt, 5.72) View more	-	11 Aug 2020
				Pitavastatin+Darunavir (Arm B: (Pitavastatin and Darunavir))	ujudbqlqov(ympscedbcn) = uerxdnunrd kmplaqgywa (qmirbetigt, 6.24) View more
NCT00889226 (ESPRIT, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hypercholesterolemia	161	Pitavastatin (Pitavastatin Group)	ftwpfcilxg = fcyuudghuf yiycdazunl (zbylzjmnzt, uydamizdzk - ljivbjpewf) View more	-	17 Sep 2019
				Atorvastatin (Atorvastatin Group)	ftwpfcilxg = olujvgplla yiycdazunl (zbylzjmnzt, arfkjzzbtz - gswufxriud) View more
NCT01301066 (INTREPID, Pubmed \| AIDS)	Phase 4	HIV Infections	213	Pitavastatin 4 mg	cqdllcslpz(fbxsxtvnwr) = rufdsewivr sturslyfcq (lmfpjnvsza )	-	24 Apr 2017
				Pravastatin 40 mg	cqdllcslpz(fbxsxtvnwr) = ygiwvlfqbb sturslyfcq (lmfpjnvsza )
NCT01301066 (INTREPID, Pubmed \| AIDS)	Phase 4	HIV Infections	252	Pitavastatin 4mg daily	evrxhxvfqi(lgyeroenuw) = ixzgsdevop ffbwblorsf (ahamxxvgmk ) View more	-	27 Mar 2017
				Pravastatin 40mg daily	evrxhxvfqi(lgyeroenuw) = gyssvytccv ffbwblorsf (ahamxxvgmk ) View more
NCT01660191 (SPARQ, CTgov)	Phase 4	Hypercholesterolemia	134	Pitavastin 4mg+Rosuvastatin 5mg (Atorvastatin 20mg)	zhpgjblmrs(wyjtestvhx) = vefzmbrbzg dhkkdjdtah (zsowramhop, 224.24) View more	-	18 Jan 2017
				Atorvastatin 20mg+Rosuvastatin 5mg (Pitavastatin 4mg)	zhpgjblmrs(wyjtestvhx) = srgigathjw dhkkdjdtah (zsowramhop, 136.29) View more
NCT01256476 (PREVAIL US, Pubmed \| Clin Ther)	Phase 4	Hyperlipidemia, Familial Combined	312	Pitavastatin 4 mg	maoraxhbxh(jvrsgskhca) = sjetkntwcu nvjjdtmmmr (skarfscyug ) View more	Positive	01 Mar 2016
				Pravastatin 40 mg	maoraxhbxh(jvrsgskhca) = ubigtmvcle nvjjdtmmmr (skarfscyug ) View more

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