→ A Chi­nese can­cer-fo­cused biotech look­ing to one-up J&J and Pfiz­er in cas­tra­tion-re­sis­tant prostate can­cer has launched its IPO in Hong Kong, look­ing to raise more than $232 mil­lion (HK$1.86 bil­lion) on the HKEX. Three cor­ner­stone in­vestors have laid claims to $98 mil­lion worth of Kin­tor Phar­ma’s shares, while oth­ers are free to bid on the rest for be­tween HK$17.8 and HK$20.15 apiece. The Jiang­su-based com­pa­ny’s lead drug, prox­a­lu­tamide, is an an­dro­gen re­cep­tor an­tag­o­nist now in Phase III tri­als in Chi­na and Phase II in the US. The stock is sched­uled to de­but on May 22.

→  A lit­tle over a month ago, Im­munomedics stock was trad­ing at less than $10 per share. Now, af­ter the FDA okayed the an­ti­body-drug con­ju­gate Trodelvy as the com­pa­ny’s first ap­proval in its 30-year his­to­ry, they’ve man­aged to sell near­ly 17 mil­lion shares at $28.50 a pop — in to­tal, a $459 mil­lion raise to aid the com­pa­ny’s com­mer­cial­iza­tion cam­paign and for­ti­fy its pipeline. With $536 mil­lion in the tank as of March 31st, per their Q1 fil­ing, the new fi­nanc­ing should give Im­munomedics a near­ly bil­lion-dol­lar war chest as they look to turn them­selves in­to a prof­it-gen­er­at­ing biotech.

→ Plagued by set­backs and dis­ap­point­ments that have sent its stock yo-yoing for the past few years, Cy­to­ki­net­ics’ $CYTK lat­est an­nounce­ment that its Am­gen-part­nered heart drug se­cured fast track sta­tus at the FDA trig­gered a near 25% surge on the shares, hit­ting $21.33 Tues­day morn­ing. The drug, ome­cam­tiv mecar­bil, is a car­diac myosin ac­ti­va­tor de­signed to treat heart fail­ure by stim­u­lat­ing a heart mus­cle pro­tein.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.