Peter Hecht spun Ironwood into two different companies after an investor attack, but the results so far leave much to be desired. (Business Wire)

Cy­cle­ri­on ax­es an­oth­er pro­gram as strug­gles grow for Pe­ter Hecht's Iron­wood spin­out

Things have not been go­ing well in the old Iron­wood pipeline.

Last month, the Boston-based phar­ma­ceu­ti­cal com­pa­ny an­nounced that the sec­ond of just two ex­per­i­men­tal drugs they had left in the pipeline failed a Phase III tri­al, trig­ger­ing sig­nif­i­cant lay­offs. And to­day, their Pe­ter Hecht-led R&D-fo­cused spin­off, Cy­cle­ri­on, an­nounced that it had al­so failed their sec­ond ma­jor study in a year, forc­ing them to aban­don the pro­gram.

Cy­cle­ri­on said to­day that a Phase II study for a drug meant to ame­lio­rate symp­toms in pa­tients with sick­le cell dis­ease “did not demon­strate ad­e­quate ac­tiv­i­ty to sup­port fur­ther clin­i­cal de­vel­op­ment.” The com­pa­ny did not re­lease any da­ta but said they would pub­lish the re­sults in a fu­ture fo­rum. They in­di­cat­ed, as they did with their pre­vi­ous tri­al miss, that they saw po­ten­tial for the com­pound, though they would not bring it for­ward.

“While we are dis­ap­point­ed that we won’t be con­tribut­ing a much-need­ed new treat­ment op­tion for SCD, we are con­tin­u­ing to an­a­lyze the da­ta to un­der­stand sev­er­al po­ten­tial bio­mark­er sig­nals, in­clud­ing in­flam­ma­tion, as we ex­plore part­ner­ship op­tions for this pro­gram,” Hecht said in a state­ment.

The sick­le cell pro­gram will be the sec­ond to bite the dust in Cy­cle­ri­on’s two-year his­to­ry. Last Oc­to­ber, a drug known as prali­ciguat that the biotech pushed in­to mid-stage tri­als failed back-to-back stud­ies on heart fail­ure and di­a­bet­ic neu­ropa­thy, cleav­ing a 68% chunk out of the stock price and forc­ing 30 lay­offs.

The com­pa­ny’s stock fell an­oth­er 44% Mon­day morn­ing, from $7.12 to $3.97.

The re­peat­ed stum­bles have dealt a sub­stan­tial blow to both Cy­cle­ri­on and Iron­wood since the two part­ed ways in the wake of an ac­tivist at­tack from in­vestor Alex Den­ner. Iron­wood was meant to fo­cus on com­mer­cial­iza­tion of an ap­proved drug and two com­pounds in Phase III. Cy­cle­ri­on, ini­tial­ly la­beled sim­ply “R&D Co.,” was meant to de­vel­op their ear­ly-stage line of cyclic guano­sine monophos­phates.

Now, the two monophos­phates that are fur­thest along have failed and Iron­wood has no drugs in its pipeline. Cy­cle­ri­on is worth about a third of its val­ue when it launched, though Iron­wood has main­tained its mar­ket cap on the back of its com­mer­cial drug Linzess.

Hecht’s fo­cus will now piv­ot to cen­tral ner­vous sys­tem dis­or­ders. The com­pa­ny an­nounced to­day re­sults from a Phase I phar­ma­col­o­gy study for a monophos­phate that can cross the blood-brain bar­ri­er. They have plans to start tri­als in two dif­fer­ent dis­or­ders: mi­to­chon­dr­i­al en­cephalomy­opa­thy, lac­tic aci­do­sis and stroke-like episodes (a sin­gle con­di­tion of­ten short-hand­ed as MELAS) and Alzheimer’s dis­ease with vas­cu­lar pathol­o­gy.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Harpreet Singh, Immatics CEO

Im­mat­ics an­nounces mul­ti­ple pipeline changes with lat­est fi­nan­cial re­sults

The T-cell biotech Immatics is looking to make some changes to its pipeline.

Immatics released its 2022 financial results on Tuesday and announced that it’s planning to discontinue its program for IMA201, an experimental cell therapy for solid tumors that express the antigens known as MAGE4/8. It plans to shift focus to IMA401, a TCR bispecific which goes after the same target.

The German-based biotech said it will treat the remaining patients enrolled in the program before the discontinuation. No other reasons were given for the discontinuation. Endpoints News reached out to Immatics for more details but did not receive a response by press time.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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