Week Ahead In Pharma: EIGR Scripts History With Progeria Treatment, LQDA, RYTM Await FDA Decision
The week ending November 20 saw some more good news on the COVID-19 front, with Pfizer (PFE) and German biotechnology company BioNTech (BNTX) making emergency use approval request to the FDA for their vaccine candidate on Friday. AstraZeneca PLC’s (AZN) Covid-19 vaccine candidate, AZD1222, licensed from the Oxford University, is better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups, revealed preliminary findings of a phase II study reported in the Lancet Journal on November 18.
Meanwhile, the number of coronavirus cases continues to rise in the U.S. – with a record daily high of 185,759 new infections registered on November 19, according to Johns Hopkins University. As of this writing, the case count in the U.S. has crossed 12 million while the number of deaths has risen to 255,800.
Three healthcare firms went public in the week – Sotera Health (SHC), Maravai Life Sciences (MRVI), and Olema Pharmaceuticals (OLMA).
Olema, which priced its IPO at $19, made its debut on the Nasdaq market on Thursday, November 19, opening at a price of $45. The stock closed Friday’s trading at $48.90.
Let’s take a look at some of the pharma stocks that merit attention in the holiday-shortened week ahead.
1. Eiger BioPharmaceuticals Inc. (EIGR)
The FDA has approved Eiger BioPharma’s Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies. The news was announced after the bell Friday and the company is scheduled to host a conference call November 23 at 8:30 AM ET to discuss the Zokinvy approval.
Progeria and Progeroid Laminopathies are serious, ultra-rare diseases characterized by premature and accelerated aging in children. It is estimated that globally, there are 400 children with Progeria and 400 children with Progeroid Laminopathies. The average life expectancy for the untreated children is around 14 years.
Zokinvy, known generically as Lonafarnib, is the first-ever treatment for Progeria and Progeroid Laminopathies.
EIGR closed Friday’s trading at $10.03, down 3.46%.
2. Sonoma Pharmaceuticals Inc. (SNOA)
Sonoma Pharma reported second fiscal quarter results after the bell Friday and also restated its first quarter financial statements for the quarter ended June 30, 2020 due to material errors.
Sonoma is a healthcare company developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, animal health care, eye care, nasal care, oral care and dermatological conditions.
Net income from continuing operations for the quarter ended September 30, 2020, was $151,000 or $0.07 per share compared to a net loss of $1.29 million or $0.98 per share in the year-earlier quarter. Revenue was $5.77 million for the second fiscal 2020 quarter, up from $4.73 million in the comparable prior-year quarter.
As for the restatement of the first quarter results, the net income has been corrected from $992,000 to $240,000, with earnings per share corrected from $0.54 to $0.13.
SNOA closed Friday’s trading at $6.63, down 0.30%.
3. Liquidia Technologies Inc. (LQDA)
Liquidia Technologies’ product candidate LIQ861, proposed for the treatment of pulmonary arterial hypertension, is at the FDA altar, awaiting a decision on November 24.
LIQ861 is a dry powder inhalation of Treprostinil. A sterile formulation of Treprostinil as an inhalation solution, developed by United Therapeutics Corp. (UTHR) is already approved by the FDA and has been marketed as Tyvaso since 2009.
Liquidia and United Therapeutics are locked in a patent dispute over Tyvaso. In a patent suit filed in June this year, United Therapeutics had alleged that Liquidia Infringed on two patents for Tyvaso, which are set to expire in December 2028.
LQDA closed Friday’s trading at $3.14, down 7.65%.
4. Rhythm Pharmaceuticals Inc. (RYTM)
The FDA decision on Rhythm Pharma’s investigational drug Setmelanotide is expected to be announced on November 27.
Setmelanotide is proposed for the treatment of two ultra-rare types of genetic obesity – pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
It is estimated that in the U.S., there are approximately 100 to 500 patients with POMC deficiency obesity and about 500 to 2,000 patients with LEPR deficiency obesity.
RYTM closed Friday’s trading at $21.37, down 2.11%.
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