(RTTNews) – Today’s Daily Dose brings you news on the FDA-mandated clinical intake of Larimar’s CTI-1601 clinical program; Pieris Pharma joins forces with Genentech de Roche; the next regulatory catalyst for Provention Bio; the possible delay at Travere in obtaining approval from Sparsentan; and the approval of Taiwan Liposome Liposomal Amphotericin B injection in India to control the growing cases of black fungi.
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1. Larimar dives on a double dose of bad news
Shares of Larimar Therapeutics, Inc. (LRMR) took a hit on Tuesday, after a double dose of bad news.
The company announced that its clinical program CTI-1601 has been suspended by the FDA and a previously announced private placement funding will be terminated.
CTI-1601 is a recombinant fusion protein in development for the treatment of Friedreich’s ataxia, a rare inherited disease caused by the inability of patients to produce sufficient amounts of a protein called frataxin. Recently, the company announced high-level positive data from its Phase I multiple-dose escalation clinical trial of CTI-1601 in Friedreich’s ataxia.
Today’s clinical shutdown follows Larimar’s previous notification to the FDA of the highest dose mortalities in an ongoing 180-day non-human primate (NHP) toxicology study designed to support prolonged dosing in patients with CTI-1601.
Before the clinical suspension was imposed, the company planned to launch an open-label extension clinical trial of CTI-1601 in patients with Friedreich’s ataxia, called the Jive study, and a multiple-dose escalating clinical trial in of patients under 18 in the second half of 2021.
Now, with the clinical suspension imposed, Larimar believes there is a possibility that the launch of these trials will be delayed until 2022.
The company also announced that it has ended the $ 95 million private placement financing announced last week. The net proceeds of 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 has noted that cash on hand stood at $ 81.4 million as of March 31, 2021, allowing cash flow through to the first half of the year. 2022.
LRMR closed Tuesday’s session at $ 13.51, down 10.59%. Outside office hours, the stock was down 45.23% to $ 7.40.
2. Pieris Pharma takes off on research collaboration with Genentech de Roche
Pieris Pharmaceuticals Inc. (PIRS) climbed more than 100% on Tuesday thanks to the company’s respiratory and ophthalmic collaboration with Roche’s Genentech.
Pieris will be responsible for the discovery, research and early preclinical development of the programs, and Genentech will be responsible for the activities enabling IND, clinical development and commercialization of these 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 potential additional milestone payments plus royalties for commercialized programs.
Pieris has two clinical drug candidates – Cinrebafusp alfa (formerly PRS 343) and PRS-060.
Cinrebafusp alfa, as monotherapy and in combination with Atezolizumab, is currently undergoing 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, in partnership with AstraZeneca, is in a Phase II study in subjects with asthma controlled by mid-dose inhaled corticosteroids.
The PIRS closed Tuesday’s session at $ 3.76, up 103.24%. In the afternoon, the stock gained another 34.84% to $ 5.07.
3. Provention Bio faces the FDA panel on May 27
Provention Bio Inc. (PRVB) gained nearly 27% on Tuesday with FDA briefing papers on its diabetes drug candidate Teplizumab, released ahead of Thursday’s advisory board meeting, appearing favorable to the company.
The company is seeking approval for Teplizumab to delay clinical type 1 diabetes mellitus (T1D) in people at risk.
Overall, Teplizumab has shown consistent benefit over placebo regardless of the underlying factors, the background papers reveal.
At the FDA Advisory Committee meeting, to be held on May 27, 2021, panel members will discuss the efficacy and safety of the drug candidate for the proposed indication and will be asked to vote whether the benefits of the drug. Teplizumab outweighs the risks in supporting 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 said there may be a delay in announcing the FDA’s decision.
PRVB closed Tuesday’s session at $ 10.12, up 26.82%. In the afternoon, 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 on Tuesday, following a regulatory update of its drug candidate Sparsentan, in development for the treatment of focal segmental glomerulosclerosis , a rare proteinuric kidney disease.
The company, whose ongoing Phase III trial of Sparsentan in focal segmental glomerulosclerosis, dubbed DUPLEX, has reached the provisional endpoint of proteinuria, continued the expedited submission of approval of its regulatory filings for Sparsentan in the United States. United and Europe.
The FDA has informed the company that the data available from the interim evaluation of the DUPLEX study would not be sufficient to support an expedited approval at this time. Based on these feedbacks, the company no longer plans to submit an application for expedited approval for FSGS in the United States in the second half of 2021.
A Type A meeting with the FDA is expected to take place in the third quarter of 2021.
In Europe, the company is expected to move forward with its plan to submit a conditional marketing authorization for Sparsentan in the second half of 2021.
TVTX closed Tuesday’s trading at $ 17.75, down 1.17%. Outside office 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-to-ten reverse stock split would become effective as of 5:00 p.m. EST 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 CEO of Novan, said: “The implementation of the reverse stock split will make available an increased number of authorized but unissued shares, which will allow us to continue fundraising activities. additional and / or other strategic transactions to support the development and potential commercialization of our product candidates, and we believe this will also help us comply with the Nasdaq minimum bid price requirement of $ 1.00 and to potentially make our stock more attractive to a wider range of institutional and other investors.
NOVN closed Tuesday’s session at $ 0.83, down 40.36%.
6. Taiwan liposome comes to the aid of India in the fight against black fungi
Liposomal Amphotericin B Injection from Taiwan Liposome Company, Ltd. (TLC) was approved in India, paving the way for immediate importation of the drug to remedy this.
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 increases in India, so does the number of COVID-19 associated mucormycosis (CAM) cases. Mucormycosis, often known as black fungus, is a dangerous fungal disease, and CAM has emerged as a serious post-COVID complication, infecting about 30% of COVID patients who are diabetic or immunosuppressed.
TLC closed Tuesday’s trading at $ 6.37, up 28.69%.
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