Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market.

A move by Chimerix Inc. to strengthen its balance sheet by $225 million through the sale of smallpox drug Tembexa (brincidofovir) to biodefense specialist Emergent Biosolutions Inc. and extend its cash runway into 2026, should have proved a big win. Instead, shares (NASDAQ:CMRX) plunged nearly 61% May 16 on worry that Chimerix might be handing off a likely profitable program to fund a riskier oncology pipeline, a concern heightened by recent U.S. FDA feedback indicating lead oncology program ONC-201 might not be eligible for accelerated approval as previously expected.

Newly appointed President and CEO Jackie Shea looks to have her work cut out for her, as Inovio Pharmaceuticals Inc. decided to ditch its phase II/III COVID-19 vaccination trial in favor of pursuing a booster strategy with INO-4800. That update, disclosed during Inovio’s first-quarter earnings late May 10 alongside a likely delay in filing for approval of HPV immunotherapy candidate VGX-3100, sent the stock (NASDAQ:INO) falling 27% May 11. Over the past year, shares have fallen more than 70%.

Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of its Smartkine cytokine drug platform.

Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.

Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of its Smartkine cytokine drug platform.

Dragonfly Therapeutics Inc. added Gilead Sciences Inc. to its roster of partnerships in a deal that gives the Waltham, Mass.-based company $300 million up front, with opt-in payments, milestones and up to 20% royalties down the road. In exchange Foster City, Calif.-based Gilead gets exclusive, worldwide rights to DF-7001, a preclinical-stage immunotherapy, as well as rights to additional NK cell engager programs generated by Dragonfly’s TriNKET (Trispecific NK Engager) platform.

As many biopharmas rethink plans to go public on less-than-welcoming U.S. markets, Hillevax Inc. forged ahead, pricing an upsized IPO April 28, offering 11.8 million shares at $17 apiece, the midpoint of its previously proposed range, for gross proceeds of about $200 million. That’s the highest amount raised in a U.S. IPO so far in 2022, which saw only nine companies go public on Nasdaq during the first quarter.