Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.

The COVID-19 pandemic sent the world into a tailspin, raising ongoing concerns about biosecurity, a subject that encompassed the better part of the morning June 16, the first day of the Biotechnology Innovation Organization’s annual conference in Boston.

Three years after litigation started over technology used in an mRNA vaccine for COVID-19, Biontech SE is acquiring its adversary, Curevac NV, through an all-stock transaction valued at about $1.25 billion. The amount is lower than the $3 billion in backpay Curevac could win through the lawsuit if a low mid-single-digit royalty were awarded, Evercore ISI analysts Jon Miller and Umer Raffat said. But the legal uncertainty has weighed heavily on the company, which shed 30% of its workforce last July and sold off rights to two of its infectious disease vaccines.

As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner.

Insmed Inc.’s chair and CEO, Will Lewis, called the phase IIb trial of TPIP in pulmonary arterial hypertension a “clear and unequivocal success,” with analysts and investors wholeheartedly agreeing, as the company’s shares surged 28.7% June 10.

As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.

Turning the human body into a biofactory of precision protein therapeutics is the focus of newly launched Signify Bio, which emerged with an oversubscribed $15 million initial financing to advance three platforms with broad potential across therapeutic areas.

Turning the human body into a biofactory of precision protein therapeutics is the focus of newly launched Signify Bio, which emerged with an oversubscribed $15 million initial financing to advance three platforms with broad potential across therapeutic areas.

Developing a therapy for an ultra-rare condition has its challenges, including finding enough patients for clinical enrollment and convincing regulatory authorities that limited data prove the candidate is safe and effective. For that reason, Stealth Biotherapeutics Inc. has faced numerous roadblocks getting its mitochondria-targeting elamipretide across the finish line for Barth syndrome, a condition that affects about 230 to 250 males worldwide, including fewer than 150 in the U.S.