Dragonfly Therapeutics, Inc.

Several top biotech executives are slated to speak at a “Make America Healthy Again” event on Wednesday that’s headlined by federal health officials, according to an agenda reviewed by Endpoints News . On a panel entitled “Making American Biotechnology Accelerate,” Regeneron co-founder and chief scientific officer George Yancopoulos will be joined by CRISPR Therapeutics CEO Sam Kulkarni and serial biotech investor Alexis Borisy, who co-founded startup accelerator Curie.Bio. It will be moderated by Amol Punjabi, described as a former special government employee at HHS and a biotech investor. The executives’ participation in the event, dubbed the MAHA Summit, is notable given how frequently Trump administration officials, including HHS Secretary Robert F. Kennedy Jr., have railed against the pharmaceutical industry and how it’s been regulated. The summit is slated to include prominent leaders across the federal health department. Kennedy will give closing remarks and FDA chief Marty Makary will participate in a fireside chat. CMS Administrator Mehmet Oz will speak to Katie Miller, a top GOP operative and wife of White House Deputy Chief of Staff Stephen Miller, alongside his deputy and top drug price negotiator Chris Klomp. Vice President JD Vance will make a keynote address. Details of the event were first reported by Politico. A spokesperson for HHS directed questions to the organizer of the event, which was not immediately clear. Opening remarks will be given by Tony Lyons, head of the Kennedy-aligned group MAHA Action; MAHA Holdings CEO Alex Hardy; and Kennedy’s son Finn, a board member of MAHA Holdings. A spokesperson for CRISPR Therapeutics said that Kulkarni was invited “to share his perspective as a leader in the field and will be discussing how gene editing has the potential to fundamentally change the treatment paradigm for patients across a range of diseases.” A spokesperson for Curie.Bio declined to comment and a spokesperson for Regeneron did not immediately respond to a request for comment. Kennedy invested in CRISPR Therapeutics prior to taking the helm of HHS. Financial disclosures ahead of his confirmation process showed that Kennedy owned between $1,000 to $15,000 in shares, which he subsequently pledged to divest . Kennedy also said in his financial disclosure that he’d divest from Dragonfly Therapeutics, a separate biotech. An HHS spokesperson did not respond to a request for comment on CRISPR’s participation in Wednesday’s event. Borisy and Curie.Bio’s participation also stand out. Curie CEO Zach Weinberg has been critical of China’s growing influence in biotech and has argued that the administration should restrict the outward flow of deals from there. He previously told Endpoints over the summer that the administration should consider executive action that would discourage US-China deals. The New York Times reported in September that there is a draft executive order that would do just that, though it’s unclear how likely that move is. In a speaking tour with biopharma executives over the summer, FDA officials — including Makary — heard from industry insiders who called on the agency to do more to expedite new trials and rival China and other nations like Australia, where earlier-stage trials have become popular. John Crowley, CEO of the trade group BIO, underscored at a Senate hearing last month that reforms are needed to keep the industry competitive in the years ahead.

Alongside the AbbVie partnership, buzzy Dragonfly has also taken flight with Merck, Gilead and Bristol Myers Squibb.\n AbbVie has scrapped an asset from its ongoing collaboration with Dragonfly Therapeutics, a spokesperson for the Chicago pharma confirmed to Fierce Biotech.“We have terminated clinical activity around ABBV-303,” the spokesperson said, alluding to a phase 1 solid tumor trial of the natural killer (NK) cell engager. “However, our partnership with Dragonfly is still ongoing.”The study was terminated in light of “strategic considerations,\" according to its entry on the federal trial database clinicaltrials.gov. AbbVie and Dragonfly were testing ABBV-303 alone and in combination with AbbVie\'s anti-PD-1 antibody budigalimab (ABBV-181).Dragonfly did not respond to multiple requests for comment from Fierce. ABBV-303 was the first asset from the AbbVie-Dragonfly team-up to hit the clinic, triggering a milestone payment for Dragonfly in March 2024. The duo forged their pact in 2019 and expanded it in 2022 to include additional targets, with a focus on oncology and autoimmune diseases.AbbVie was studying the candidate in solid tumors expressing c-Met, the company spokesperson said, which is a receptor protein commonly found on the surface of tumor cells.“This termination does not impact our commitment to continue advancing c-Met targeted therapies,” the spokesperson added.Dragonfly’s pipeline is packed with Big Pharma collaborations and a clutch of wholly owned assets, the most advanced of which is DF1001, a HER2-targeting NK cell engager currently in a phase 1/2 trial for non-small cell lung cancer and metastatic breast cancer.Alongside the AbbVie partnership, buzzy Dragonfly has also taken flight with Merck,  Gilead and Bristol Myers Squibb, with BMS also once dumping an asset back into Dragonfly’s pond.

Plus, news about Cybin, Incyte, Roche, Merck, Eisai, Neuphoria Therapeutics, Aldeyra Therapeutics and X4 Pharmaceuticals: 🏭 FDA issues CRL to Regeneron: The drugmaker has officially been handed a complete response letter for its pre-filled syringe for Eylea HD. The company had warned in August that it expected regulatory delays after issues were found at a Catalent site in Bloomington, IN, that’s now owned by Novo Nordisk. The plant has since been issued an “official action indicated” classification. Another customer of the Indiana site, Scholar Rock, also received a CRL related to the plant. — Anna Brown 🧪 AbbVie scraps asset licensed from Dragonfly Therapeutics: The Chicago-area pharma giant terminated a Phase 1 test of the first asset that it licensed from Dragonfly . AbbVie started testing ABBV-303/DF4101 in 2024 in solid tumors. Dragonfly CEO Bill Haney told Endpoints News that the company’s other programs with AbbVie are ongoing. Dragonfly has multiple internal candidates in clinical testing as well as Phase 1 programs with Bristol Myers Squibb and Merck. It also has a preclinical pact with Gilead. — Kyle LaHucik 💵 Cybin’s $175M direct offering: The company is selling about 22.3 million shares at $6.51 apiece from several blue-chip investors, including Venrock Healthcare Capital Partners, OrbiMed and Point72. It’s developing a psychedelic called CYB003 as a treatment for major depressive disorder. — Jaimy Lee 🛠️ Incyte halts work on two drugs: Under new CEO Bill Meury, the drugmaker has paused development of its anti-CD122 candidate, called INCA034460, and its BET inhibitor, called INCB57643. The biotech also ended povorcitinib’s development in chronic spontaneous urticaria and hinted that more pipeline adjustments are in the works. “We are taking a deliberate approach to pipeline prioritization. We are actively reviewing our R&D efforts and focusing on high-value programs that are scientifically differentiated, address unmet medical needs, and have the potential to significantly drive Incyte’s next phase of growth,” Meury said in a release.  Incyte also raised its revenue guidance for the year. It’s now in the range of $4.23 billion to $4.32 billion. — Kyle LaHucik 🔬 Roche’s Gazyva succeeds in kidney disorder: The drug met its primary endpoint in a Phase 3 study for idiopathic nephrotic syndrome, a rare autoimmune disease that affects the kidneys. Roche will head to the FDA to discuss next steps for the drug, but the timing is not yet clear. Gazyva was approved earlier this month for the treatment of active lupus nephritis. — Max Gelman 💊 Merck, Eisai tout kidney cancer data: The combination of Merck’s Welireg and Eisai’s Lenvima achieved a statistically significant improvement in progression-free survival over Exelixis’ Cabometyx in advanced renal cell carcinoma. Overall survival did not reach statistical significance, though Merck and Eisai noted this was an interim analysis. There was also a “trend toward improvement” on OS. — Max Gelman 📈 Neuphoria Therapeutics adopts poison pill after Phase 3 fail: The biotech’s board selected the shareholder rights plan to “protect the interest of the company and its stockholders.” The move lowers the chances that a person or group will accumulate enough shares to control Neuphoria. The biotech’s social anxiety drug failed a Phase 3 trial last week, and the company decided to drop the asset, named BNC210. The biotech’s stock price $NEUP was up almost 6% in premarket trading on Tuesday. — Kyle LaHucik 💼 Aldeyra Therapeutics updates its pipeline: The biotech discontinued work on ADX-629 in patients with Sjögren-Larsson Syndrome. It also said it expects to file INDs for a pair of RASP modulators sometime next year. — Jaimy Lee 💰 X4 Pharmaceuticals ended up raising $155.3 million in its public offering, up from the $135 million it set out to raise. — Jaimy Lee