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21/09/2026

A ketamine-based depression treatment launched seven years ago helped shape a new network of interventional psychiatry clinics across the U.S.

When the treatment first reached market, there were relatively few specialized clinics with the space, staff, and expertise needed to administer it. The environment was described as very underdeveloped and requiring a huge investment.

That early investment appears to have paid off. The treatment generated more than $1 billion in the first half of this year, and thousands of interventional psychiatry clinics now operate across the U.S.

This shift reflects how patient access and clinic capacity can change over time. What stands out most to you about this growth?

19/09/2026

The Food and Drug Administration has approved Fayuvi, the first gene therapy for the rare progressive neurological condition Sanfilippo syndrome Type A.

Key details from the announcement include:

Fayuvi is priced at $3.95 million.
It is now the second gene therapy Ultragenyx Pharmaceuticals has brought to market since August.
Neither of the two therapies is projected by analysts to become a blockbuster product.
Ultragenyx received sellable drug review vouchers alongside both approvals, which may significantly bolster the company’s balance sheet.
Ultragenyx also warned of coming cost cuts after the failure of an Angelman syndrome drug with larger sales potential.

Company shares climbed by double digits after the approval.

How do you view the commercial outlook for newly approved rare disease gene therapies?

18/09/2026

Novo is investing in oral biologics through a new deal with Orbis Medicines to discover multiple macrocycles with the potential to replace injectable medicines.

The agreement could bring Orbis as much as $1.4 billion in upfront and downstream payments, plus sales royalties.

The companies did not specify how many drugs are included or which diseases will be targeted, but they said the work will focus on unnamed cardiometabolic targets.

The deal reflects Novo’s effort to address limitations in standard oral peptide medicines, including poor digestive absorption. The highest dose of Novo’s Wegovy pill contains 20 times the highest injectable dose because most of the active ingredient is broken down before reaching the bloodstream.

How significant do you see oral biologics becoming for cardiometabolic treatment?

17/09/2026

Roche is committing $36.5 million upfront in a partnership with Dualitas Therapeutics to screen more than 300,000 potential bispecific antibody combinations for immune disease research.

The agreement gives Roche the option to advance a limited number of programs, while Dualitas may develop any programs not selected at a later date.

Dualitas could receive up to $1 billion in future milestone payments and is also eligible for future sales royalties.

This deal points to continued interest in experimental medicines for immune diseases. What stands out most about this partnership?

16/09/2026

The Food and Drug Administration has approved Bexlutry, Curium’s first generic radioligand therapy for cancer. The clearance makes Bexlutry a copycat version of Novartis’ Lutathera and the first generic targeted radiopharmaceutical of its kind.

Bexlutry delivers radioactive lutetium to SSTR, a protein found on the surface of certain neuroendocrine tumors. Its use covers SSTR-positive neuroendocrine cancers, including foregut, midgut and hindgut tumors.

The approval came after Curium prevailed in a patent dispute with Novartis.

How do you see this approval shaping the next phase of radioligand therapy?

15/09/2026

The Food and Drug Administration has approved apitegromab, to be sold as Isembyld, for spinal muscular atrophy, or SMA.

The treatment is cleared for use alongside existing targeted therapies in adults with SMA and in children at least 2 years of age. For a typical SMA patient, executives said the annual list price will be about $310,000 per year, with costs varying based on weight and insurance coverage.

Key details:
• Approved for use with existing targeted therapies
• Available for adults with SMA and children 2 years and older
• Annual list price for a typical patient is about $310,000

The approval adds a new option for a rare genetic disease that had no approved medicines as recently as a decade ago. How do you see this approval affecting SMA care?

12/09/2026

Karyopharm Therapeutics has reached a deal with creditors that gives the company more time to address a $15.8 million debt payment due Thursday.

Under the agreement, lenders, noteholders, and royalty investors will hold off on taking action through Oct. 15. That gives Karyopharm a little over a month to negotiate, pursue strategic alternatives, or seek additional financing.

As part of the deal, Karyopharm will pay a $20 million fee in newly issued convertible stock.

The company is also waiting to see whether U.S. regulators will accept an approval application for its multiple myeloma drug Xpovio in myelofibrosis.

How do you view this latest move, short-term relief or a sign of deeper pressure?

11/09/2026

Biohaven disclosed that the Food and Drug Administration has placed a partial hold on an experimental epilepsy medicine tied to opakalim, prompting a pause in recruitment for one late-stage trial.

The agency asked for more data about a metabolite identified in rodent studies. Dosing will continue for participants already enrolled in the RISE-2 study.

Key points:
• The separate late-stage RISE-3 trial is fully enrolled and remains on track for results later this year.
• Biohaven said the hold does not affect RISE-3.
• If opakalim succeeds in testing and wins approval, Biohaven could receive milestone payments and sales royalties from SK Pharmaceuticals.

Biohaven shares fell more than 10% on Thursday after the disclosure. How do you see the next stage of development playing out?

10/09/2026

The Trump administration has installed permanent leaders in two critical Food and Drug Administration roles after a period of turbulence at the agency.

Michael Davis will now serve permanently as director of the Center for Drug Evaluation and Research. Karim Mikhail will become full-time director of the Center for Biologics Evaluation and Research after leading the division in an interim role.

The administration also created a new FDA post for Jared Seehafer, who will be the first deputy commissioner for technology and artificial intelligence. Bret Koplow will serve as director of the Center for To***co Products.

These leadership decisions come at a time when industry leaders and investors have been watching the agency closely. How do you view these staffing changes?

09/09/2026

Solstice Oncology has emerged from stealth with $225 million in financing to develop new immunotherapies aimed at a difficult cancer target.

Its lead program, porustobart, is a CTLA-4 antibody that is being tested in colon cancer patients before they receive other treatments. The drug is expected to enter mid-stage testing by the end of the year.

Porustobart was licensed from Harbour Biomed in February under a deal that included a $105 million upfront payment and could reach $1.2 billion in total value.

The Series A round included RA Capital Management, Canaan Partners, and Forbion. What stands out most about this development?

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