Today’s Daily Dose brings you news about the clinical hold imposed by the FDA on Larimar’s CTI-1601 clinical program; Pieris Pharma teaming up with Roche’s Genentech; the upcoming regulatory catalyst of Provention Bio; the possible delay in Travere seeking approval for Sparsentan; and the approval of Taiwan Liposome’s Liposomal Amphotericin B injection in India to fight the growing cases of black fungus.
1. Larimar Plunges On Double Dose Of Bad News
Shares of Larimar Therapeutics, Inc. (LRMR) took a hit Tuesday, following a double dose of bad news.
The company announced that its CTI-1601 clinical program has been placed on hold by the FDA and that a previously announced private placement financing will be terminated.
CTI-1601 is a recombinant fusion protein being developed as a treatment for Friedreich ataxia, a rare inherited disease caused by patients’ inability to produce sufficient amounts of a protein called frataxin. Recently, the company announced positive topline data from its phase I multiple ascending dose clinical trial of CTI-1601 in Friedreich’s Ataxia.
Today’s clinical hold follows the previous notification by Larimar to the FDA of mortalities which occurred at the highest dose levels in an ongoing 180-day non-human primate (NHP) toxicology study, which is designed to support extended dosing of patients with CTI-1601.
Before the clinical hold was imposed, the company was expecting to initiate an open-label extension clinical trial of CTI-1601 in Friedreich’s Ataxia patients, dubbed the Jive study, and a multiple ascending dose clinical trial in patients under 18 years of age in the second half of 2021.
Now, with the clinical hold imposed, Larimar believes there is a possibility that the initiation of these trials may be delayed into 2022.
The company has also announced that it has terminated the $95 million private placement financing that was announced last week. The net proceeds from the private placement were intended to support the clinical development of CTI-1601.
Now, with the termination of the previously announced private placement financing, the company noted cash on hand was $81.4 million as of March 31, 2021, which provides cash runway through the first half of 2022.
LRMR closed Tuesday’s trading at $13.51, down 10.59%. In after-hours, the stock was down another 45.23% to $7.40.
2. Pieris Pharma Soars on Research Collaboration with Roche’s Genentech
Pieris Pharmaceuticals Inc. (PIRS) soared over 100% on Tuesday on the back of the company’s respiratory and ophthalmology collaboration with Roche’s Genentech.
Pieris will be responsible for discovery, research and early preclinical development of the programs, and Genentech will be responsible for IND-enabling activities, clinical development, and commercialization of those programs.
As part of the deal, Pieris will receive $20 million as an upfront payment and is entitled to receive over $1.4 billion in additional potential milestone payments plus royalties for commercialized programs.
Pieris has two clinical drug candidates – Cinrebafusp alfa (formerly known as PRS 343) and PRS-060.
Cinrebafusp alfa, as monotherapy and in combination with Atezolizumab, is currently in phase I studies for the treatment of HER2-positive solid tumors. The company is preparing for the phase II study of Cinrebafusp alfa, which is expected to begin in the summer of 2021.
PRS-060, also known as AZD1402, partnered with AstraZeneca, is under a phase II study in subjects with asthma controlled on medium dose inhaled corticosteroids.
PIRS closed Tuesday’s trading at $3.76, up 103.24%. In after-hours, the stock gained another 34.84% to $5.07.
3. Provention Bio Faces FDA Panel On May 27
Provention Bio Inc. (PRVB) gained nearly 27% on Tuesday with the FDA briefing documents on its diabetes drug candidate Teplizumab, released ahead of the Thursday’s advisory committee meeting, looking favorable for the company.
The company is seeking approval of Teplizumab to delay clinical type 1 diabetes mellitus (T1D) in at-risk individuals.
Overall, Teplizumab demonstrated consistent benefit over placebo regardless of baseline factors, reveals the briefing documents.
In the FDA advisory committee meeting, which is to be held on May 27, 2021, the panel members will discuss the effectiveness and safety of the drug candidate for the proposed indication and will be asked to vote if the benefits of Teplizumab outweigh the risks in support of approval to delay clinical type 1 diabetes mellitus.
The regulatory agency’s final decision is expected to be announced on July 2, 2021. However, late last month, the company had announced that there could be a delay in announcing the FDA decision.
PRVB closed Tuesday’s trading at $10.12, up 26.82%. In after-hours, the stock gained another 8.10% to $10.94.
4. FDA Says ‘Not Now Travere’
Shares of Travere Therapeutics Inc. (TVTX) fell more than 8% in extended trading Tuesday, following a regulatory update its drug candidate Sparsentan, being developed as a treatment for focal segmental glomerulosclerosis, a rare proteinuric kidney disorder.
The company, whose ongoing phase III trial of Sparsentan in focal segmental glomerulosclerosis, dubbed DUPLEX, achieved the interim proteinuria endpoint, has been in pursuit of accelerated approval submission of its regulatory filings for Sparsentan in the U.S. and Europe.
The FDA has informed the company that the available data from the interim assessment of the DUPLEX Study would not be adequate to support an accelerated approval at this time. Based upon this feedback, the company no longer expects to submit for accelerated approval for FSGS in the U.S. during the second half of 2021.
A Type A meeting with the FDA is expected to occur in the third quarter of 2021.
In Europe, the company is expected to move ahead with its plan of making a conditional marketing authorization submission for Sparsentan in the second half of 2021.
TVTX closed Tuesday’s trading at $17.75, down 1.17%. In after-hours, the stock fell 8.45% to $16.25.
5. Novan Implements Reverse Stock Split
Shares of Novan Inc. (NOVN) plunged 40% on Tuesday after the company announced that a one-for-ten reverse stock split will become effective as of 5:00 p.m. Eastern Time on May 25, 2021.
The company’s common stock is expected to begin trading on a split-adjusted basis when the market opens on May 26, 2021.
Paula Brown Stafford, President and Chief Executive Officer of Novan, said, “Implementing the Reverse Stock Split will make available an increased number of authorized but unissued shares allowing us to pursue additional financing activities and/or other strategic transactions to support the development and potential commercialization of our product candidates, and we believe it will also help us maintain compliance with Nasdaq’s $1.00 minimum bid price requirement and potentially make our stock more attractive to a broader range of institutional and other investors.”
NOVN closed Tuesday’s trading at $0.83, down 40.36%.
6. Taiwan Liposome Comes to India’s Rescue To Fight Black Fungus
Taiwan Liposome Company, Ltd.’s (TLC) Liposomal Amphotericin B injection has been approved in India, paving way for immediate importation of the drug to tackle its shortage there.
Liposomal Amphotericin B injection, known as Ampholipad in Taiwan and AmphoTLC in India, is indicated for severe systemic fungal infections such as mucormycosis.
As the number of COVID-19 infections rises in India, so does the number of COVID-19 associated mucormycosis (CAM) cases. Mucormycosis, often known as black fungus, is a dangerous fungal illness, and CAM has emerged as a serious post-COVID complication, infecting about 30% of COVID patients who are diabetic or otherwise immunocompromised.
TLC closed Tuesday’s trading at $6.37, up 28.69%.
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