Biogen beats Q2 consensus; EPS guidance tops estimates

Biogen (BIIB) Q2 results:

Revenues: $3,682M (+1.8%).

Net Income: $1,542M (+3.2%); EPS: $9.59 (+22.2%); non-GAAP Net Income: $1,651M (-5.2%); non-GAAP EPS: $10.26 (+12.1%).

CF Ops: $1,948M.

Key product sales: Spinraza sales: $495M (+1%); Tecfidera: $1,182M (+3%); Tysabri: $432M (-9%); Avonex: $389M (-11%); Rituxan/Gazyva: $270M (-31%); Ocrevus royalties: $208M (+14%); Benepali: $106M (-12%).

2020 Guidance: Revenue: $13.8B – 14.2B from prior range of $14.0B – 14.3B. The midpoint for analyst expectations was $13.92B; GAAP EPS: $32.00 – $34.00 from $29.50 – $31.50; Non-GAAP EPS: $34.00 – $36.00 from prior guidance of $31.50 – $33.50. The midpoint for analyst expectations was $32.93.

https://seekingalpha.com/news/3593527-biogen-beats-q2-consensus-eps-guidance-tops-estimates

Roche eye implant shows sustained benefit in wet macular degeneration

July 22, 2020

Following up on its first announcement two months ago, Roche (OTCQX:RHHBY +0.3%) reports detailed results from its successful Phase 3 clinical trial, ARCHWAY, evaluating its Port Delivery System (PDS) with ranibizumab in patients with neovascular age-related macular degeneration (wet AMD). The data will be presented virtually on Sunday, July 26, at the American Society of Retina Specialists Annual Meeting.

98.4% of PDS patients were able to go six months without additional treatment while achieving vision outcomes equivalent to those receiving monthly eye injections, implying twice-yearly treatment, 83% less frequent than current standard of care.

PDS is a permanent refillable eye implant about the size of a grain of rice that continuously delivers a customized formulation of ranibizumab (branded as Lucentis in the injectable format) over a period of months.

PDS is being assessed in another Phase 3, PAGODA, in patients with diabetic macular edema.

Marketing applications in the U.S. and Europe for wet AMD are next up.

https://seekingalpha.com/news/3593706-roche-eye-implant-shows-sustained-benefit-in-wet-amd-study

Qualigen secures rights to lineup of RAS inhibitor cancer candidates

Qualigen Therapeutics (QLGN -3.6%) has signed a worldwide license agreement with the University of Louisville for “RAS-F” family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates.

The company will evaluate these compounds in order to identify a lead drug candidate for further development against one or more cancers.

UofL royalties will receive low-to-mid-single-digit percentages on net sales of RAS protein-protein licensed products.

https://seekingalpha.com/news/3593694-qualigen-secures-rights-to-lineup-of-ras-inhibitor-cancer-candidates

Transgene up on positive HPV therapeutic vaccine data

Ultra-thinly traded micro cap Transgene (OTCPK:TRGNF +9.0%) is up, albeit on turnover of only 2,100 shares, on the heels of a pooled analysis of data from a Phase 1b/2 clinical trial evaluating its HPV16-targeted therapeutic vaccine TG4001, combined with Pfizer (PFE +3.7%) and Merck KgaA’s (OTCPK:MKKGY -1.4%) PD-L1 blocker Bavencio (avelumab), in 34 patients with recurrent and/or metastatic HPV16-positive tumors that progressed after one-to-three lines of chemo.

The analysis showed that TG4001 can be safely combined with an immune checkpoint inhibitor.

On the efficacy front, clinical activity was observed in the overall population. The company says it has identified a selection criterion corresponding to high responders. In more than half of these patients, progression-free survival was 12 weeks, half again as long as the average of eight weeks with current regimens.

It is conducting the study in collaboration with Merck KgaA, although Transgene says it has stopped it in its current design.

Final results will be submitted for presentation at a future medical conference.

A larger confirmatory trial is next up.

https://seekingalpha.com/news/3593711-transgene-up-9-on-positive-hpv-therapeutic-vaccine-data

Alpha Pro Tech up 11% as Ohio institutes mask order

The continued proliferation of mask wearing orders is bullish for personal protective gear maker Alpha Pro Tech (APT +11.2%). Ohio Governor Mike DeWine’s order will take effect at 6 pm today.

29 U.S. states now have such requirements.

Compatriots Allied Healthcare Products (AHPI +11.7%) and Lakeland Industries (LAKE +3.8%) are up as well.

https://seekingalpha.com/news/3593834-alpha-pro-tech-up-11-ohio-institutes-mask-order

Altimmune secures supply of COVID-19 nasal spray vaccine

Altimmune (NASDAQ:ALT) inks an agreement with Rockville, MD-based CDMO Vigene Biosciences to manufacture its single-dose intranasal COVID-19 vaccine candidate AdCOVID.

The company is in talks with additional partners aimed at producing at least 100M doses next year.

A Phase 1 clinical trial in healthy volunteers should launch in Q4.

https://seekingalpha.com/news/3593537-altimmune-secures-supply-of-covidminus-19-nasal-spray-vaccine

RedHill to expand study of Yeliva for COVID-19

RedHill Biopharma (NASDAQ:RDHL) has filed an application in Mexico and has initiated an application in Brazil to add sites to its global Phase 2/3 clinical trial evaluating Yeliva (opaganib, ABC294640) on top of standard-of-care treatment in severely ill hospitalized COVID-19 patients with pneumonia.

The 270-subject study was previously approved in Russia and the UK. The primary endpoint will be the proportion of patients requiring intubation and mechanical ventilation by day 14 compared to placebo.

Enrollment in an ongoing Phase 2 study in up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen should be completed next month although it is not powered for statistical significance.

If all goes well, the company believes it may file applications for emergency use in Q4.

https://seekingalpha.com/news/3593547-redhill-to-expand-study-of-yeliva-for-covidminus-19