Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

Private Company Edition: ReCode’s series B venture capital round grew for a third time, now totaling $260m for precision genetic medicines. Also, DalCor closed an $80m series D, manufacturer Nephron amassed $350m, Hyku launched with a $56m seed financing and Magnet emerged with $50m.

The UK-based company has replaced its single head of research with four therapy area-focused leaders as it looks to further boost R&D productivity.

Ampersand Biomedicines has emerged from stealth mode with a new CEO, and aims to shake up oncology and immunology with a new tissue-specific approach to targeting medicines.

Emerging Company Profile: BioAge has Phase Ib proof-of-concept data in age-related muscle loss and is gearing up for its first Phase II study, but will need fresh cash or a partner for a potential weight loss-related muscle loss study.

These are interesting times for Mironid, a Glasgow-based biotech developing small molecule therapeutics for the treatment of autosomal dominant polycystic kidney disease, a life-threatening hereditary condition.

The founder and MD of investment bank Candle Partners reflects on key pharma M&A trends over the years and the shape of things to come including private equity action and how family-owned firms are weighing monetization and diversification options.

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

The Merck & Co vaccine for human papillomavirus Gardasil, along with Johnson & Johnson’s Darzalex for multiple myeloma, entered the ranks of the top 10 best-selling drugs globally in the second quarter. There was no product for COVID-19 in the line-up for the first time since 2020.

An infographic looking at commercial factors for the 10 drugs chosen for Medicare price negotiation in 2026 under the Inflation Reduction Act (IRA). The graphics below review the valuations of these drugs, both past and forecast, as well as their relative contributions to the top-lines of the companies that own them.

The Class of ’26 of Medicare Price Negotiation University is now on stage. Our infographic profiles who they are and where they come from, breaking down the $50.5B in gross annual Part D spending, about 20% of the total.

Deal Snapshot: The Danish drug maker plans to pay up to $2.7bn to Flagship Pioneering-incubated Valo Health for its AI-enabled small molecule discovery and human genetic data platform.

Deal Snapshot: Looking to add to its neuroscience pipeline, Takeda acquires rights to the antisense candidate AS-202 from AcuraStem for development as a potential amyotrophic lateral sclerosis therapy.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer expects Jardiance’s new chronic kidney disease indication to keep its sales growing by double-digit percentages over the coming years, aided by the drug’s ability to reduce hospitalizations.

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

The announcement that LEAP-006 and LEAP-008, both in non-small cell lung cancer, did not meet their primary endpoints adds to a string of failures for the combination.

Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

Recent executive moves in the industry include new CEOs at Rentschler Biopharma, MedinCell and OncoZenge, plus C-suite changes at Hinova Pharmaceuticals and ImmunoGen.

Once again choosing their words carefully, the partners talk only of ‘plans’ to file as regulators will first have to clarify when overall survival data will be required for the new antibody-drug conjugate in breast cancer.

BenevolentAI has added Merck KGaA to its list of partners but the UK firm is looking for a new CEO after Joanna Shields decided to leave as a major restructuring continues.

Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.