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The FDA has signed off on Insmed’s brensocatib, to be marketed as Brinsupri, for the daily treatment of non-cystic fibrosis bronchiectasis for adults and kids 12 years and up.

According to the company, Brinsupri’s approval marks two milestones for the industry: it is the first FDA approval for a DPP1 inhibitor and the first treatment cleared for the chronic pulmonary disorder.

Brinsupri’s approval opens up a completely new therapeutic class: DPP1 inhibitors. Expressed by neutrophils, DPP1 is an enzyme that plays a role in triggering the inflammatory response in airways. (BioSpace)

With the FDA approval of its zongertinib in certain non-small cell lung cancer (NSCLC) patients, 175-year-old Boehringer Ingelheim is entering the oncology market.

Zongertinib, which will be sold as Hernexeos, was specifically approved to treat previously treated NSCLC patients who have the relatively rare HER2 activating mutations in the tyrosine kinase domain (TKD).

It’s a patient population that has a “huge unmet need” and is estimated to be comprised of about 40,000 people across the globe, according to the company.

The mutated cancer type occurs in approximately 2% to 4% of NSCLC cases. Hernexeos is now the first FDA-approved oral treatment that can specifically target the disease, marking a welcome chemo-free treatment option for patients. (Fierce Pharma)

Canada-based PharmaTher received FDA approval for its ketamine therapy for surgical pain management, KETARx (racemic ketamine), on its third attempt.

This comes after two previous rejections in April 2024 and October 2024, each citing minor deficiencies in the abbreviated new drug applications (aNDAs) for the therapy in anesthesia, mental health, neurological indications, pain and sedation.

Ketarx’s approval marks the first time the FDA has approved a ketamine product in an analgesic setting. (Pharmaceutical Technology)

Bayer will partner with Kumquat Biosciences to develop Kumquat’s KRAS G12D inhibitor through a collaboration that could generate up to $1.3 billion-plus for the San Diego biotech, while bolstering Bayer’s early precision oncology portfolio with a potential treatment for pancreatic, colorectal, and lung cancer, the companies said.

The collaboration comes after the FDA last month cleared Kumquat’s investigational new drug (IND) application to begin clinical trials of the KRAS G12D inhibitor.

Bayer and Kumquat reason that while KRAS mutations occur in nearly 25% of human cancers, G12D is the most prevalent oncogenic KRAS variant that still lacks effective treatment options. (Genetic Engineering & Biotechnology News)

Using its hub-and-spoke business model, PureTech is launching a new company to develop deupirfenidone (LYT-100), its promising candidate for idiopathic pulmonary fibrosis (IPF) and other fibrotic and inflammatory lung conditions.

PureTech has established Celea Therapeutics with a “mission to transform the treatment of respiratory diseases,” the Boston-based company said in a release this week.

Running the London-listed subsidiary is former Teva North America CEO Sven Dethlefs, Ph.D., who has orchestrated the development of deupirfenidone for PureTech for the last year-plus. (Fierce Biotech)

Vor Biopharma said a late-stage study run in China by its partner RemeGen succeeded, showing that treatment with an experimental drug called telitacicept helped reduce disease activity in people with the autoimmune condition Sjögren’s syndrome.

Vor didn’t share any specifics, but noted RemeGen plans to ask China’s health regulator for approval of telitacicept in Sjögren’s.

The fusion protein drug is already cleared there to treat lupus, rheumatoid arthritis and generalized myasthenia gravis.

Vor’s deal to license telitacicept was one of several dozen inked this year that brought drug candidates invented in China into the pipelines of U.S.- and Europe-based firms. (BioPharma Dive)

The last IPO was Feb. 13, when Aardvark Therapeutics debuted on the Nasdaq. Its share price $AARD is about 30% lower today.

By comparison, there were more than 50 biotech IPOs from Feb. 13 to Aug. 13 in 2021, when it felt like nearly any company could land a ticker.

However, many investors were burned during that period, and industry leaders agreed that the pace was unsustainable.

Some companies that went public in the pandemic gold rush have since shuttered, including Omega Therapeutics. Others were acquired, like Ambrx Biopharma (by Johnson & Johnson) and Verve Therapeutics (by Eli Lilly).

There was a nearly five-month bleak period for IPOs in 2022 and an approximately seven-month hiatus in 2011, if you don’t count Horizon’s $49 million IPO. At the time, it was considered a specialty pharma company with an approved drug.

It has forced venture capitalists and other investors to write larger checks to keep existing portfolio companies chugging along. And it’s led some biotechs to opt for a deal instead.

Developed by the pharmaceutical company LENZ, VIZZ is an aceclidine ophthalmic treatment in the form of once-daily drops that ease near-object blurriness for up to 10 hours.

But unlike similar eye drops that arrived in recent years, VIZZ appears to avoid annoying side effects and rare medical complications.

It’s often an inevitable consequence of time—your eyes’ lenses naturally harden as you get older, making it increasingly difficult for the optical muscles to adjust between focal points.

Participants didn’t report any serious issues across the over 30,000 cumulative treatment days.