Kailera Therapeutics Inc.’s “obesity-first” approach continues to resonate with investors, with the company pricing an upsized IPO, offering 39 million shares at $16 apiece for gross proceeds of $625 million. Full exercise of the underwriters’ option could add another $93.8 million, bringing the total to nearly $719 million, easily topping Sana Biotechnology Inc.’s $675.6 million 2021 IPO and setting a new record for U.S. biopharma IPOs, according to BioWorld data.

“Unprecedented,” “remarkable” and “transformative” were just a few of the descriptives tossed out by Wall Street analysts in response to Revolution Medicines Inc.’s phase III readout, showing RAS inhibitor daraxonrasib hit its overall survival and progression-free survival endpoints in previously treated patients with metastatic pancreatic ductal adenocarcinoma, setting up the company for potential regulatory filings this year and triggering another round of M&A speculation.

Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.

Founded amid the booming next-generation antibody-drug conjugate (ADC) space, Sidewinder Therapeutics Inc. has emerged from stealth with an oversubscribed $137 million series B round and plans to advance a lead program into the clinic in 2027.

Founded amid the booming next-generation antibody-drug conjugate (ADC) space, Sidewinder Therapeutics Inc. has emerged from stealth with an oversubscribed $137 million series B round and plans to advance a lead program into the clinic in 2027.

Just over a month after emerging from stealth and disclosing a $150 million series A, Korsana Biosciences Inc. is making the leap to the public market via a merger with Cyclerion Therapeutics Inc.  The agreement, which is backed by a $370 million private placement from Korsana’s investors, solidly positions the newly merged company as it heads toward the clinic with KRSA-028, a next-generation shuttled antibody targeting amyloid beta for the treatment of Alzheimer’s disease, and builds out a pipeline of neurodegenerative disease candidates.

Just over a month after emerging from stealth and disclosing a $150 million series A, Korsana Biosciences Inc. is making the leap to the public market via a merger with Cyclerion Therapeutics Inc.  The agreement, which is backed by a $370 million private placement from Korsana’s investors, solidly positions the newly merged company as it heads toward the clinic with KRSA-028, a next-generation shuttled antibody targeting amyloid beta for the treatment of Alzheimer’s disease, and builds out a pipeline of neurodegenerative disease candidates.

Eli Lilly and Co. anticipates shipping newly approved Foundayo (orforglipron) within the next week, as the drug becomes the second oral weight-loss glucagon-like peptide-1 (GLP-1) receptor agonist to enter the U.S. market following December’s approval of Novo Nordisk A/S’ Wegovy (semaglutide) pill.

United Therapeutics Corp. is eyeing a possible priority review in its anticipated supplemental NDA for Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) after the second phase III trial hit its endpoints, even besting the impressive findings from the first phase III study reported last year, and positioning United for a substantial commercial launch in 2027.

In a win for the rare disease space, the U.S. FDA granted accelerated approval for Rocket Pharmaceuticals Inc.’s Kresladi (marnetegragene autotemcel) as the first gene therapy option for treating severe leukocyte adhesion deficiency-I (LAD-I), an ultrarare genetic immune disorder characterized by an immunodeficiency predisposing those affected to recurrent and fatal infections.