Gami­da Cell prices its fol­low-on pub­lic of­fer­ing at $20M; Rally­bio touts Phase Ib da­ta for mon­o­clon­al an­ti­body

While Gami­da Cell is still charg­ing its way to­ward ap­proval for its ther­a­pies with new CEO Abi­gail Jenk­ins in place, it’s look­ing to gar­ner a lit­tle more cash.

The com­pa­ny an­nounced on Wednes­day that it will be of­fer­ing up over 12 mil­lion shares and ex­pect­ing pro­ceeds of an es­ti­mat­ed $20 mil­lion. The of­fer is ex­pect­ed to close on Sept. 30. Ac­cord­ing to Gami­da Cell, it plans to use the cash to help with the po­ten­tial launch of its omidu­bi­cel ther­a­py if it gets ap­proval. Omidu­bi­cel has a PDU­FA date set for Jan. 30, 2023.

If the ther­a­py does get the thumbs-up, the com­pa­ny plans to al­so use the cash to con­tin­ue the de­vel­op­ment of its oth­er can­di­dates and for oth­er cor­po­rate pur­pos­es.

Rally­Bio gives an ear­ly look at its Phase Ib re­sults for mon­o­clon­al an­ti­body

The rare dis­ease biotech Rally­Bio is get­ting ready to re­veal its ini­tial Phase Ib re­sults for one of its can­di­dates.

The com­pa­ny said Wednes­day that it has pre­sent­ed pre­lim­i­nary re­sults in its Phase IB proof-of-con­cept study for its mon­o­clon­al an­ti­body, dubbed RLYB212. The can­di­date aims to pre­vent fe­tal and neona­tal al­loim­mune throm­bo­cy­tope­nia (FNAIT).

Mar­tin Mack­ay

The da­ta re­port­ed­ly showed that one week af­ter a sin­gle dose, lev­els of trans­fused HPA-1a pos­i­tive platelets went down rapid­ly when put up against a place­bo, in a mod­el of a “cat­a­stroph­ic fe­tal ma­ter­nal he­m­or­rhage.” Ear­ly da­ta al­so show the po­ten­tial for dos­ing less fre­quent­ly.

“These pre­lim­i­nary re­sults con­tin­ue to sup­port our pro­ject­ed ef­fec­tive tar­get ther­a­peu­tic con­cen­tra­tions for the pre­ven­tion of ma­ter­nal HPA-1a al­loim­mu­niza­tion by RLYB212. We are pleased to see the rapid and com­plete elim­i­na­tion of trans­fused platelets in all sub­jects to date, with a greater than 90% re­duc­tion of the mean platelet elim­i­na­tion half-life com­pared to place­bo, con­sis­tent with our proof-of-con­cept cri­te­ria,” Rally­Bio CEO Mar­tin Mack­ay said in a state­ment.

Mack­ay al­so stat­ed that the full da­ta will be pre­sent­ed some­time in the first quar­ter of 2023.

Max­Cyte inks a strate­gic plat­form li­cense with Ver­tex to build out its CRISPR pro­gram

Mary­land-based biotech Max­Cyte is work­ing with a ma­jor com­pa­ny to ad­vance its CRISPR pro­gram.

Max­Cyte has signed a li­cens­ing deal with Ver­tex Phar­ma­ceu­ti­cals. The deal will have Ver­tex gain rights to use Max­Cyte’s CRISPR/Cas-9-based gene edit­ing plat­form both com­mer­cial­ly and in the clin­ic, though those rights aren’t ex­clu­sive. In the deal, Max­Cyte will get li­cens­ing fees and oth­er rev­enue re­lat­ed to the pro­gram. How­ev­er, the fi­nan­cial de­tails of the deal were not re­vealed.

The plat­form it­self, ac­cord­ing to Max­Cyte, is a gene-edit­ed cell ther­a­py that is meant to treat pa­tients with sick­le cell dis­ease.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.